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NCT04650880Recruiting

Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome

A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome

Source: ClinicalTrials.gov · Last updated 14 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a randomized double-blind controlled trial on the effect of vitamin D supplementation to assess the ovulation rate of women with polycystic ovary syndrome (PCOS) and other reproductive, endocrine and metabolic outcomes after one year of treatment.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
220 (estimated)
First submitted
19 Nov 2020
Start date
26 Jan 2021
Primary completion date
31 Dec 2024
Lead sponsor
The University of Hong Kong
NCT number
NCT04650880

What you commit to

  • Study type: Interventional
  • Planned participants: 220
  • From 26 Jan 2021 to the primary completion date, 31 Dec 2024
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of hormonal medication (including contraception) within 3 months prior to study inclusion, except the use of a progestogen to induce withdrawal bleeding every 3 months
  • Use of insulin-sensitizing drugs, lipid lowering drugs or anti-hypertensive
  • Anticipated to use the above medications in the coming one year

Other illness

  • History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants
  • Known type 2 diabetes mellitus

Lab values

  • Abnormal blood calcium level
    • For those on supplements, we asked them to stop their own supplements.

Other

  • Refusal to join the study

Who the study is looking for

  • Premenopausal
  • Aged 18-40 years
  • Irregular long menstrual cycles (\>35 days)
  • PCOS according to the Rotterdam criteria
  • Agree for transvaginal ultrasound

Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Margaret Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaNot yet recruiting
Kwong Wah Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaRecruiting
Queen Mary Hospital University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.